Parkinson DiseaseSomnomat CasaNCT06386497
Acceptability of the Somnomat Casa for the Treatment of Parkinson's Disease
A study testing Nocturnal translational vestibular stimulation in people with Parkinson Disease, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
Trial summary
This pilot study aims to evaluate the feasibility and acceptability of nocturnal translational vestibular stimulations (VS) applied by a rocking bed (Somnomat Casa) for two months in patients with Parkinson's Disease. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Nocturnal translational vestibular stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 11 Jan 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed Consent signed by the subject
- PD according to the MDS clinical diagnostic criteria for Parkinson's disease
- Suffering from reduced sleep quality as defined by pathological cut-off (score of > 5) on the Pittsburgh Sleep Quality Index (PSQI)
- Patients with stable antiparkinsonian, antidepressant, and sleep medications for six weeks before intervention and maintained on stable medication during the intervention period
- Treatment without bilateral deep brain stimulation
- Fluent in German
Who cannot join
- Brain disease other than Parkinson's disease (e.g. atypical Parkinsonism, Alzheimer's disease, vascular dementia, multiple sclerosis, stroke, traumatic brain injury, epilepsy, etc.).
- Dementia as defined by a MOCA score lower than 24/30
- Weight > 150kg
- Depression with acute suicidal ideation
- Presence of major ongoing psychiatric illness such as acute non-controlled psychosis
- Poor general health (e.g. non-controlled diabetes, uncontrolled arterial hypertension, therapy for malignancy)
Show all 9Show fewer
- Inability to follow the procedures of the study, e.g. filling out patient questionnaires due to language problems, psychological disorders, dementia, etc. of the participant
- Participation in another interventional trial within the 30 days preceding and during the present study
- Participants with PSQI score lower or equal 5
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
Insel Gruppe AG, University Hospital Bern
Bern, 3010
Lenard Lachenmayer, MD, 31 664 12 59 ext. +41, lenard.lachenmayer@insel.ch
- Not yet recruiting
ETH Zurich, Sensory-Motor Systems Lab, IRIS
Zurich, 8092
Robert Riener, Prof., 44 632 66 79 ext. +41, robert.riener@hest.ethz.ch
About this study
Official title: Overnight Treatment of Parkinson's Disease Using Vestibular Stimulation From a Rocking Bed (Somnomat Casa) - A Feasibility Study
This pilot study aims to evaluate the feasibility and acceptability of nocturnal translational vestibular stimulations (VS) applied by a rocking bed (Somnomat Casa) for two months in patients with Parkinson's Disease.
Read the detailed description
Twelve PD patients will receive overnight VS in their familiar home environment for two months via the rocking bed. Participants will be given questionnaires to obtain feedback on the acceptability of the nocturnal intervention device.
Effects on sleep, motor and non-motor symptoms, and quality of life will be assessed using the appropriate validated scales and questionnaires. The corresponding assessments will be performed before, during, and two month after the intervention.
Unobtrusive pressure-sensitive textiles and bioradar will be used to record physiological variables such as body position, movements, breathing rate, and heart rate to correlate them to the clinical assessments as well as to markers obtained from actigraphy devices that the patients will be wearing throughout the study.
The primary feasibility outcomes include rate of accrual and retention, adherence to the protocol, acceptability and satisfaction with intervention using rocking bed specific questionnaires, semi-structured interviews, and data collected automatically from the bed.
To assess the preliminary effectiveness of the intervention the secondary outcomes are the change in subjective sleep quality, daytime sleepiness, PD related sleep disorders, mentation, behaviour, mood, activities of daily living, motor performance, and quality of life.
- Conditions
- Parkinson Disease
- Being tested
- Nocturnal translational vestibular stimulation
- Keywords
- Vestibular Stimulation, Sleep quality, Rocking bed, Feasibility
- Medical subject headings
- Parkinson Disease, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nocturnal translational vestibular stimulationDevice
Nocturnal (overnight) translational vestibular stimulation applied by the rocking bed (Somnomat Casa) for two months in patients familiar home environment.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease patients | Experimental | All included Parkinson's disease patients Receives: Device: Nocturnal translational vestibular stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of acceptability and feasibility
The acceptability and feasibility of the translational vestibular stimulation with the Somnomat Casa will be evaluated with a custom-designed questionnaire. The questionnaire consists of 22 questions including questions with five-point likert scale and open questions ("I fully agree" to "I do not agree at all").
Measured: At Visit 1 (1 month after start of intervention)
Evaluation of acceptability and feasibility
The acceptability and feasibility of the translational vestibular stimulation with the Somnomat Casa will be evaluated with a custom-designed questionnaire. The questionnaire consists of 22 questions including questions with five-point likert scale and open questions ("I fully agree" to "I do not agree at all").
Measured: At Visit 2, at the end of the intervention (after 2 months)
Secondary outcomes (28)
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, assessing a broad range of domains associated with sleep quality, including: usual sleep wake patterns, duration of sleep, sleep latency, the frequency and severity of specific sleep-related problems, and the perceived impact of poor sleep on daytime functioning.
Measured: At Baseline Visit (before the intervention)
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, assessing a broad range of domains associated with sleep quality, including: usual sleep wake patterns, duration of sleep, sleep latency, the frequency and severity of specific sleep-related problems, and the perceived impact of poor sleep on daytime functioning.
Measured: At Visit 1 (1 month after start of intervention)
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, assessing a broad range of domains associated with sleep quality, including: usual sleep wake patterns, duration of sleep, sleep latency, the frequency and severity of specific sleep-related problems, and the perceived impact of poor sleep on daytime functioning.
Measured: At Visit 2, at the end of the intervention (after 2 months)
Pittsburgh Sleep Quality Index (PSQI)
The PSQI is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, assessing a broad range of domains associated with sleep quality, including: usual sleep wake patterns, duration of sleep, sleep latency, the frequency and severity of specific sleep-related problems, and the perceived impact of poor sleep on daytime functioning.
Measured: At Final Visit (two months after the intervention)
Epworth Sleepiness Scale (ESS)
The ESS is a short self-administered questionnaire designed to assess daytime sleepiness. This basic test involves a self-assessment of how likely a person is to fall asleep in eight different situations.
Measured: At Baseline Visit (before the intervention)
Epworth Sleepiness Scale (ESS)
The ESS is a short self-administered questionnaire designed to assess daytime sleepiness. This basic test involves a self-assessment of how likely a person is to fall asleep in eight different situations.
Measured: At Visit 1 (1 month after start of intervention)
Epworth Sleepiness Scale (ESS)
The ESS is a short self-administered questionnaire designed to assess daytime sleepiness. This basic test involves a self-assessment of how likely a person is to fall asleep in eight different situations.
Measured: At Visit 2, at the end of the intervention (after 2 months)
Epworth Sleepiness Scale (ESS)
The ESS is a short self-administered questionnaire designed to assess daytime sleepiness. This basic test involves a self-assessment of how likely a person is to fall asleep in eight different situations.
Measured: At Final Visit (two months after the intervention)
Parkinson's Disease Sleep Scale version 2 (PDSS-2)
The PDSS-2 is a patient-completed clinical rating scale that assesses the frequency of sleep disturbances over the past week. The PDSS-2 covers three domains: motor symptoms at night, PD specific symptoms at night and disturbed sleep.
Measured: At Baseline Visit (before the intervention)
Parkinson's Disease Sleep Scale version 2 (PDSS-2)
The PDSS-2 is a patient-completed clinical rating scale that assesses the frequency of sleep disturbances over the past week. The PDSS-2 covers three domains: motor symptoms at night, PD specific symptoms at night and disturbed sleep.
Measured: At Visit 1 (1 month after start of intervention)
Parkinson's Disease Sleep Scale version 2 (PDSS-2)
The PDSS-2 is a patient-completed clinical rating scale that assesses the frequency of sleep disturbances over the past week. The PDSS-2 covers three domains: motor symptoms at night, PD specific symptoms at night and disturbed sleep.
Measured: At Visit 2, at the end of the intervention (after 2 months)
Parkinson's Disease Sleep Scale version 2 (PDSS-2)
The PDSS-2 is a patient-completed clinical rating scale that assesses the frequency of sleep disturbances over the past week. The PDSS-2 covers three domains: motor symptoms at night, PD specific symptoms at night and disturbed sleep.
Measured: At Final Visit (two months after the intervention)
Restless Legs Syndrome Rating Scale (IRLS)
IRLS is a 10-item questionnaire to assess the severity of the Restless Legs Syndrome (RLS).
Measured: At Baseline Visit (before the intervention)
Restless Legs Syndrome Rating Scale (IRLS)
IRLS is a 10-item questionnaire to assess the severity of the Restless Legs Syndrome (RLS).
Measured: At Visit 1 (1 month after start of intervention)
Restless Legs Syndrome Rating Scale (IRLS)
IRLS is a 10-item questionnaire to assess the severity of the Restless Legs Syndrome (RLS).
Measured: At Visit 2, at the end of the intervention (after 2 months)
Restless Legs Syndrome Rating Scale (IRLS)
IRLS is a 10-item questionnaire to assess the severity of the Restless Legs Syndrome (RLS).
Measured: At Final Visit (two months after the intervention)
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
The MDS-UPDRS is a scale used to measure the severity of PD. A higher score denotes greater disability. It includes four parts: mentation, behaviour and mood (MDS-UPDRS I); activities of daily living (MDS-UPDRS II); motor examination MDS-UPDRS III); complication of treatment (MDS-UPDRS IV).
Measured: At Baseline Visit (before the intervention)
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
The MDS-UPDRS is a scale used to measure the severity of PD. A higher score denotes greater disability. It includes four parts: mentation, behaviour and mood (MDS-UPDRS I); activities of daily living (MDS-UPDRS II); motor examination MDS-UPDRS III); complication of treatment (MDS-UPDRS IV).
Measured: At Visit 1 (1 month after start of intervention)
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
The MDS-UPDRS is a scale used to measure the severity of PD. A higher score denotes greater disability. It includes four parts: mentation, behaviour and mood (MDS-UPDRS I); activities of daily living (MDS-UPDRS II); motor examination MDS-UPDRS III); complication of treatment (MDS-UPDRS IV).
Measured: At Visit 2, at the end of the intervention (after 2 months)
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
The MDS-UPDRS is a scale used to measure the severity of PD. A higher score denotes greater disability. It includes four parts: mentation, behaviour and mood (MDS-UPDRS I); activities of daily living (MDS-UPDRS II); motor examination MDS-UPDRS III); complication of treatment (MDS-UPDRS IV).
Measured: At Final Visit (two months after the intervention)
Parkinson's disease quality of life questionnaire (PDQ-39)
The Parkinson's disease quality of life questionnaire evaluates the disease specific QoL. This questionnaire quantifies disease-specific and disease-referred quality of life in PD patients. In 39 items 8 main dimensions are interrogated (mobility, activities of daily living, emotional well-being, stigma, social support, cognitive impairment, communication and bodily discomfort). Each of these 8 domains contributes equally to a summary index of overall disease specific QoL.
Measured: At Baseline Visit (before the intervention)
Parkinson's disease quality of life questionnaire (PDQ-39)
The Parkinson's disease quality of life questionnaire evaluates the disease specific QoL. This questionnaire quantifies disease-specific and disease-referred quality of life in PD patients. In 39 items 8 main dimensions are interrogated (mobility, activities of daily living, emotional well-being, stigma, social support, cognitive impairment, communication and bodily discomfort). Each of these 8 domains contributes equally to a summary index of overall disease specific QoL.
Measured: At Visit 1 (1 month after start of intervention)
Parkinson's disease quality of life questionnaire (PDQ-39)
The Parkinson's disease quality of life questionnaire evaluates the disease specific QoL. This questionnaire quantifies disease-specific and disease-referred quality of life in PD patients. In 39 items 8 main dimensions are interrogated (mobility, activities of daily living, emotional well-being, stigma, social support, cognitive impairment, communication and bodily discomfort). Each of these 8 domains contributes equally to a summary index of overall disease specific QoL.
Measured: At Visit 2, at the end of the intervention (after 2 months)
Parkinson's disease quality of life questionnaire (PDQ-39)
The Parkinson's disease quality of life questionnaire evaluates the disease specific QoL. This questionnaire quantifies disease-specific and disease-referred quality of life in PD patients. In 39 items 8 main dimensions are interrogated (mobility, activities of daily living, emotional well-being, stigma, social support, cognitive impairment, communication and bodily discomfort). Each of these 8 domains contributes equally to a summary index of overall disease specific QoL.
Measured: At Final Visit (two months after the intervention)
Patients' Global Impression of Severity Scale (PGIS)
The Patient Global Impression of Severity scale is a single, self-administered question asking respondents about the severity of their current general condition.
Measured: At Baseline Visit (before the intervention)
Patients' Global Impression of Change Scale (PGICS)
The Patient Global Impression of Change scale is a single, self-administered question asking respondents to rate how their condition has changed since a certain point in time.
Measured: At Visit 1 (1 month after start of intervention)
Patients' Global Impression of Change Scale (PGICS)
The Patient Global Impression of Change scale is a single, self-administered question asking respondents to rate how their condition has changed since a certain point in time.
Measured: At Visit 2, at the end of the intervention (after 2 months)
Patients' Global Impression of Change Scale (PGICS)
The Patient Global Impression of Change scale is a single, self-administered question asking respondents to rate how their condition has changed since a certain point in time.
Measured: At Final Visit (two months after the intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2024
- Study start11 Jan 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- ETH Zurich
- Responsible party
- Sponsor
- Investigators
- Lenard Lachenmayer, MD, Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06386497
- Sponsor's protocol ID
- 2023-D0100
- Acronym
- Somnomat Casa
- Status last verified
- May 2026
- First submitted
- 15 Apr 2024
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Overnight Treatment of Parkinson's Disease Using Vestibular Stimulation From a Rocking Bed (Somnomat Casa) - A Feasibility Study
- ClinicalTrials.gov ID
- NCT06386497
- Acronym / sponsor ID
- Somnomat Casa / 2023-D0100
- Conditions
- Parkinson Disease
- Keywords
- Vestibular Stimulation, Sleep quality, Rocking bed, Feasibility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- ETH Zurich
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study aims to evaluate the feasibility and acceptability of nocturnal translational vestibular stimulations (VS) applied by a rocking bed (Somnomat Casa) for two months in patients with Parkinson's Disease.
Detailed description
Twelve PD patients will receive overnight VS in their familiar home environment for two months via the rocking bed. Participants will be given questionnaires to obtain feedback on the acceptability of the nocturnal intervention device.
Effects on sleep, motor and non-motor symptoms, and quality of life will be assessed using the appropriate validated scales and questionnaires. The corresponding assessments will be performed before, during, and two month after the intervention.
Unobtrusive pressure-sensitive textiles and bioradar will be used to record physiological variables such as body position, movements, breathing rate, and heart rate to correlate them to the clinical assessments as well as to markers obtained from actigraphy devices that the patients will be wearing throughout the study.
The primary feasibility outcomes include rate of accrual and retention, adherence to the protocol, acceptability and satisfaction with intervention using rocking bed specific questionnaires, semi-structured interviews, and data collected automatically from the bed.
To assess the preliminary effectiveness of the intervention the secondary outcomes are the change in subjective sleep quality, daytime sleepiness, PD related sleep disorders, mentation, behaviour, mood, activities of daily living, motor performance, and quality of life.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease patients | Experimental | Device: Nocturnal translational vestibular stimulationAll included Parkinson's disease patients |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Informed Consent signed by the subject
- PD according to the MDS clinical diagnostic criteria for Parkinson's disease
- Suffering from reduced sleep quality as defined by pathological cut-off (score of > 5) on the Pittsburgh Sleep Quality Index (PSQI)
- Patients with stable antiparkinsonian, antidepressant, and sleep medications for six weeks before intervention and maintained on stable medication during the intervention period
- Treatment without bilateral deep brain stimulation
Key exclusion criteria (9 listed)
- Brain disease other than Parkinson's disease (e.g. atypical Parkinsonism, Alzheimer's disease, vascular dementia, multiple sclerosis, stroke, traumatic brain injury, epilepsy, etc.).
- Dementia as defined by a MOCA score lower than 24/30
- Weight > 150kg
- Depression with acute suicidal ideation
- Presence of major ongoing psychiatric illness such as acute non-controlled psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nocturnal translational vestibular stimulationNocturnal (overnight) translational vestibular stimulation applied by the rocking bed (Somnomat Casa) for two months in patients familiar home environment. | Device | Parkinson's disease patients |
Primary outcome
Evaluation of acceptability and feasibility
Time frame: At Visit 1 (1 month after start of intervention)
The acceptability and feasibility of the translational vestibular stimulation with the Somnomat Casa will be evaluated with a custom-designed questionnaire. The questionnaire consists of 22 questions including questions with five-point likert scale and open questions ("I fully agree" to "I do not agree at all").
Evaluation of acceptability and feasibility
Time frame: At Visit 2, at the end of the intervention (after 2 months)
The acceptability and feasibility of the translational vestibular stimulation with the Somnomat Casa will be evaluated with a custom-designed questionnaire. The questionnaire consists of 22 questions including questions with five-point likert scale and open questions ("I fully agree" to "I do not agree at all").
28 secondary outcomes
Pittsburgh Sleep Quality Index (PSQI)
Time frame: At Baseline Visit (before the intervention)
Pittsburgh Sleep Quality Index (PSQI)
Time frame: At Visit 1 (1 month after start of intervention)
Pittsburgh Sleep Quality Index (PSQI)
Time frame: At Visit 2, at the end of the intervention (after 2 months)
Pittsburgh Sleep Quality Index (PSQI)
Time frame: At Final Visit (two months after the intervention)
Epworth Sleepiness Scale (ESS)
Time frame: At Baseline Visit (before the intervention)
Epworth Sleepiness Scale (ESS)
Time frame: At Visit 1 (1 month after start of intervention)
Epworth Sleepiness Scale (ESS)
Time frame: At Visit 2, at the end of the intervention (after 2 months)
Epworth Sleepiness Scale (ESS)
Time frame: At Final Visit (two months after the intervention)
Parkinson's Disease Sleep Scale version 2 (PDSS-2)
Time frame: At Baseline Visit (before the intervention)
Parkinson's Disease Sleep Scale version 2 (PDSS-2)
Time frame: At Visit 1 (1 month after start of intervention)
Parkinson's Disease Sleep Scale version 2 (PDSS-2)
Time frame: At Visit 2, at the end of the intervention (after 2 months)
Parkinson's Disease Sleep Scale version 2 (PDSS-2)
Time frame: At Final Visit (two months after the intervention)
Restless Legs Syndrome Rating Scale (IRLS)
Time frame: At Baseline Visit (before the intervention)
Restless Legs Syndrome Rating Scale (IRLS)
Time frame: At Visit 1 (1 month after start of intervention)
Restless Legs Syndrome Rating Scale (IRLS)
Time frame: At Visit 2, at the end of the intervention (after 2 months)
Restless Legs Syndrome Rating Scale (IRLS)
Time frame: At Final Visit (two months after the intervention)
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: At Baseline Visit (before the intervention)
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: At Visit 1 (1 month after start of intervention)
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: At Visit 2, at the end of the intervention (after 2 months)
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: At Final Visit (two months after the intervention)
Parkinson's disease quality of life questionnaire (PDQ-39)
Time frame: At Baseline Visit (before the intervention)
Parkinson's disease quality of life questionnaire (PDQ-39)
Time frame: At Visit 1 (1 month after start of intervention)
Parkinson's disease quality of life questionnaire (PDQ-39)
Time frame: At Visit 2, at the end of the intervention (after 2 months)
Parkinson's disease quality of life questionnaire (PDQ-39)
Time frame: At Final Visit (two months after the intervention)
Patients' Global Impression of Severity Scale (PGIS)
Time frame: At Baseline Visit (before the intervention)
Patients' Global Impression of Change Scale (PGICS)
Time frame: At Visit 1 (1 month after start of intervention)
Patients' Global Impression of Change Scale (PGICS)
Time frame: At Visit 2, at the end of the intervention (after 2 months)
Patients' Global Impression of Change Scale (PGICS)
Time frame: At Final Visit (two months after the intervention)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lenard Lachenmayer, MD principal investigator
Insel Gruppe AG, University Hospital Bern
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nocturnal translational vestibular stimulation in people with Parkinson Disease, run by Insel Gruppe AG, University Hospital Bern at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lenard Lachenmayer, MD (31 66 4 12 59 ext. +41, lenard.lachenmayer@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of acceptability and feasibility (time frame: At Visit 1 (1 month after start of intervention)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.